Obesity has become a worldwide challenge with significant health and socioeconomic implications. One of the major implications is its impact on drug therapy. In order to gain a better understanding of this impact, we surveyed the regulatory guidances, the newly approved molecular entity drug products, and drug product labels in the Physician's Desk Reference. This review summarizes the findings of the survey along with the existing knowledge on pharmacokinetic and pharmacodynamic changes associated with obesity.
An early detection of functional decline with age is important to start interventions at an early state and to prolong the functional fitness. In order to assure such an early detection, functional assessments must be conducted on a frequent and regular basis. Since the five time chair rise test (5CRT) is a well-established test in the geriatric field, this test should be supported by technology. We introduce an approach that automatically detects the execution of the chair rise test via an inertial sensor integrated into a belt. The system’s suitability was evaluated via 20 subjects aged 72–89 years (78.2 ± 4.6 years) and was measured by a stopwatch, the inertial measurement unit (IMU), a Kinect® camera and a force plate. A Multilayer Perceptrons-based classifier detects transitions in the IMU data with an F1-Score of around 94.8%. Valid executions of the 5CRT are detected based on the correct occurrence of sequential movements via a rule-based model. The results of the automatically calculated test durations are in good agreement with the stopwatch measurements (correlation coefficient r = 0.93 (p < 0.001)). The analysis of the duration of single test cycles indicates a beginning fatigue at the end of the test. The comparison of the movement pattern within one person shows similar movement patterns, which differ only slightly in form and duration, whereby different subjects indicate variations regarding their performance strategies.
Changes that accompany older age can alter the pharmacokinetics (PK), pharmacodynamics (PD), and likelihood of adverse effects (AEs) of a drug. However, older adults, especially the oldest or those with multiple chronic health conditions, polypharmacy, or frailty, are often under‐represented in clinical trials of new drugs. Deficits in the current conduct of clinical evaluation of drugs for older adults and potential steps to fill those knowledge gaps are presented in this communication. The most important step is to increase clinical trial enrollment of older adults who are representative of the target treatment population. Unnecessary eligibility criteria should be eliminated. Physical and financial barriers to participation should be removed. Incentives could be created for inclusion of older adults. Enrollment goals should be established based on intended treatment indications, prevalence of the condition, and feasibility. Relevant clinical pharmacology data need to be obtained early enough to guide dosing and reduce risk for participation of older adults. Relevant PK and PD data as well as patient‐centered outcomes should be measured during trials. Trial data should be analyzed for differences in PK, PD, effectiveness, and safety arising from differences in age or from the presence of conditions common in older adults. Postmarket evaluations with real‐world evidence and drug labeling updates throughout the product lifecycle reflecting new knowledge are also needed. A comprehensive plan is needed to ensure adequate evaluation of the safety and effectiveness of drugs in older adults.
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